RS-OIL 5700

HIGH PURITY STERILE SILICONE OIL, 5700 cSt, 15 ML FOR INTRAOCULAR TAMPONADE

SILICONE OIL
RS-OIL 5700 RS-OIL is highly purified
100% silicone oil, obtained from the mixture of long and silicone oil (100% pure
Ingredient
short molecular chains (100% polydimethylsiloxane) polydimethylsiloxane),
Viscosity (25°C) 5415 - 5985 cSt 5700 cSt, 15 ml, sterile and
Specific gravity (25°C) 0.967 - 0.975 apyrogenic, packaged in
Refractive index (25°C) 1.40 vial, intended for long-term
Acidity index ≤ 0.15 ml NaOH 0.01 N replacement of the vitreous
Heavy metals ≤ 5 ppm humour extracted during
Phenolic compounds ≤ 0.20 (250 - 270 nm) vitreoretinal surgery. Product
Volatility (10g/24h/150°C) ≤ 0.10 %w/w warrants a stable tamponade
Bacterial endotoxins < 0.2 EU/ml over the time and reduced
Non-cytotoxic according to ISO 10993-5, incidence of complications.
direct contact test performed on two cell lines:
Cytotoxicity Test
- retinal pigment epithelial cells (ARPE-19)
- mouse fibroblasts cells (BALB 3T3 clone A31)
Form sterile fluid
Volume 15 ml
Packaging vial in medical pouch
Sterilization moist heat according to EN ISO 17665-1
Storage temperature room temperature
Ref.: RSO 009-00
Expiry date 36 months
Intended use intraocular tamponade during vitreoretinal surgery
Class medical device
Contents:
GMDN code P 45125  1 RS-OIL 5700 vial (100%
CND code Q 02030202 high purity, sterile silicone
MD registration number 971029/R oil 5700 cSt, 15 ml)
Medical device class IIb  3 labels for product
CE mark CE 0477 traceability
 1 package insert

GS1-128 barcode

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